S-1 in Combination With Abraxane in Treating Cholangiocarcinoma | RxWiki

S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

Overview[ - collapse ][ - ]

Purpose	This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
Condition	Cholangiocarcinoma
Intervention	Drug: S-1 plus Abraxane
Phase	Phase 2
Sponsor	Yuhong Li
Responsible Party	Sun Yat-sen University
ClinicalTrials.gov Identifier	NCT01963325
First Received	September 26, 2013
Last Updated	October 11, 2013
Last verified	October 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 26, 2013
Last Updated Date	October 11, 2013
Start Date	August 2013
Estimated Primary Completion Date	December 2014
Current Primary Outcome Measures	Response rates [Time Frame: 6 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	Progression-free survival [Time Frame: 6 months] [Designated as safety issue: No] Number of participants with adverse events [Time Frame: 12 months] [Designated as safety issue: Yes]Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.

Descriptive Information[ + expand ][ + ]

Brief Title	S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Official Title	Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
Brief Summary	This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
Detailed Description	There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Cholangiocarcinoma
Intervention	Drug: S-1 plus Abraxane Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment. Other Names: Paclitaxel Albumin-Bound Particles for Injectable Suspension Gimeraciland Oteracil Porassium Capsules
Study Arm (s)	Experimental: S-1 plus Abraxane Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	40
Estimated Completion Date	December 2014
Estimated Primary Completion Date	October 2014
Eligibility Criteria	Inclusion Criteria: - Histologic or cytologic diagnosis of cholangiocarcinoma - Not eligible for curative surgery - Progressed after first-line gemcitabine-based chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better - No serious or uncontrolled concomitant medical illness - Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method). Exclusion Criteria: - Uncontrolled infection or severe active comorbid disease - Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer - Pregnancy or lactating women
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01963325
Other Study ID Numbers	S1vsNab-P20130819
Has Data Monitoring Committee	Yes
Information Provided By	Sun Yat-sen University
Study Sponsor	Yuhong Li
Collaborators	Not Provided
Investigators	Principal Investigator: Yuhong Li, MD Sun Yat-sen University
Verification Date	October 2013

Locations[ + expand ][ + ]